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Scan Body
EUDAMEDClass I (EU MDR)
Ref 7680120Model Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8Ref 7680093Model Orion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8Ref 7680095Ref 7680127Model Orion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8Ref 7680124Ref 7680126
Identity
- Trade Name
- Scan Body EUDAMED
- Device Name
- Scan Body EUDAMED
- Model / Reference
- Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8 EUDAMED7680120 EUDAMEDOrion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8 EUDAMED7680093 EUDAMED7680095 EUDAMEDOrion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8 EUDAMED7680127 EUDAMED7680124 EUDAMED7680126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877826697 EUDAMED06941877826628 EUDAMED06941877826642 EUDAMED06941877826765 EUDAMED06941877826734 EUDAMED06941877826758 EUDAMED
- Basic UDI-DI
- 697259778EM011MK EUDAMED697259778EM013MP EUDAMED697259778EM012MM EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Scan Body by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697259778EM011MK | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (6)
- EUDAMED 384edb44-72ec-4132-86bb-e865e0c6b078 61 fields · synced Jul 21, 2026
- EUDAMED 33c0a09b-0b29-4fb9-9ffa-3c0fe397c638 61 fields · synced May 16, 2026
- EUDAMED bb477ab4-8cd4-40f3-8221-723a9dcf74d1 61 fields · synced May 17, 2026
- EUDAMED 0022e969-ca2f-4d92-9a91-0f6b5964854d 61 fields · synced May 17, 2026
- EUDAMED 8e7abad2-e933-4116-b3ae-12e65c205f23 61 fields · synced May 18, 2026
- EUDAMED 7e81014e-ff47-41b4-982e-44fdf16d47fc 61 fields · synced May 18, 2026